NCT07065747

Brief Summary

The goal of this study is to determine if it's possible to use a high resolution imaging device called optical coherence tomography (OCT) to develop an unbiased, standard method of counting and categorizing the various types of cells and proteins found in an eye condition called anterior uveitis. Anterior uveitis is a type of inflammation in the eye that can be caused by many different diseases of the body.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Sep 2024Dec 2026

Study Start

First participant enrolled

September 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

July 2, 2025

Last Update Submit

July 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identification & Measurement of Anterior Chamber Cells

    Anterior Chamber (AC) cells will be identified from OCT images by computer algorithms. AC cell number counted by OCT will be correlated with slit lamp grading. Cell size \& other characteristics identified from OCT images will be associated with different uveitis diagnostic categories. The Standardization of Uveitis Nomenclature (SUN) grading system (scale: 0 = none to 4+ = severe) will be used to compare OCT-derived quantification against slit-lamp grading performed by attending physicians.

    Day 1

Secondary Outcomes (4)

  • Measure of AC Flare

    Day 1

  • Measure of Keratic Precipitates

    Day 1

  • Measure of Vitreous Cells

    Day 1

  • Measurement of Vitreous Haze

    Day 1

Study Arms (3)

Uveitis Group

Eyes with active inflammation due to various systemic diseases

Posterior Vitreous Detachment Group

Eyes with vitreous floaters and posterior vitreous detachment

Healthy/Control Group

Healthy eyes with no history of uveitis, posterior vitreous detachment, or previous eye surgery

Eligibility Criteria

Age5 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be recruited from clinical practices of the investigators at Casey Eye Institute of Oregon Health \& Science University in Portland, Oregon.

You may qualify if:

  • Uveitis Group: Eyes with active intraocular inflammation and a clinical diagnose of spondyloarthritis/HLA-B27 associated anterior uveitis, Juvenile Idiopathic Arthritis (JIA) associated chronic anterior uveitis, Herpes Simplex Virus (HSV) anterior uveitis, Birdshot chorioretinitis, Behcet disease uveitis, sarcoidosis associated uveitis, uveitis of any additional type, or uveitis masquerade.
  • Posterior Vitreous Detachment Group: Eyes with vitreous floaters and posterior vitreous detachment (PVD).
  • Healthy/Control Group: Healthy eyes with no history of uveitis, PVD, or previous eye surgery.

You may not qualify if:

  • Inability to give informed consent.
  • Inability to maintain stable fixation for OCT imaging.
  • Inability to commit to required visits to complete the study.
  • Pregnancy and breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casey Eye Institute - Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Uveitis, AnteriorBirdshot ChorioretinopathyBehcet SyndromeHerpes SimplexArthritis, JuvenileSpondylarthritisSarcoidosisVitreous Detachment

Condition Hierarchy (Ancestors)

PanuveitisUveitisUveal DiseasesEye DiseasesChorioretinitisRetinitisRetinal DiseasesChoroiditisChoroid DiseasesUveitis, PosteriorWhite Dot SyndromesAutoimmune DiseasesImmune System DiseasesMouth DiseasesStomatognathic DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSpondylitisSpinal DiseasesBone DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivity

Study Officials

  • Yan Li, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Humberto Martinez, COT, MBA

CONTACT

Denzil Romfh, OD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 15, 2025

Study Start

September 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations